ST Pharm said it was having a pre-IND (investigational new drug) meeting with the U.S. FDA for a phase 2 trial of an HIV drug, after completing the phase 1 study in France.
The Kosdaq-listed company aims to develop the world’s first cure for HIV.
On Monday, ST Pharm said in a public filing that it received the clinical study report (CSR) on the results of the phase 1 study of STP0404, an HIV treatment candidate, in France. The phase 1 trial was double-blind, placebo-controlled, and randomized.
The phase 1 study aimed to evaluate the single ascending dose (SAD) between 200mg and 400mg, the multiple ascending dose (MAD) between 200mg and 600mg, and the food effect in healthy male volunteers.
The study reported no treatment-related serious adverse events. In tests for signs and electrocardiogram, there was no clinically meaningful adverse reaction, the company said.
ST Pharm emphasized that the highest dose did not cause any significant side effects and found no maximum tolerated dose (MTD) during the study.
STP0404 showed consistent pharmacodynamic profiles and the company confirmed that the treatment exposure increased proportionally to the treatment dose.
ST Pharm plans to announce the results of the phase 1 study of STP0404 at the 24th International AIDS Conference to be held in Montreal, Canada, from July 29 to Aug. 2.
The company said it was having a pre-IND meeting with the FDA for a phase 2 study. It also said it would test the drug in a phase 2a study in adults who were infected with HIV-1 and had not received a drug prescription.
ST Pharm is conducting joint research with Emory University and Colorado State University to find a cure for AIDS.
The U.S. National Institutes of Health selected STP0404 as its research support project in May 2018.
“The results of the phase 1 study of STP0404 are in contrast to those of other drugs with the same mechanism that could not enter a phase 1 study due to serious adverse events,” ST Pharm said. “The latest study is expected to raise STP0404’s clinical value as a potential first-in-class.”
STP0404 is an allosteric HIV-1 integrase inhibitor (ALLINI). By targeting the non-catalytic site of integrase, the drug candidate removes the genetic material of the AIDS virus from the capsid and fundamentally blocks the virus's proliferation, according to the company.
Because existing integrase inhibitors such as MSD’s Isentress (raltegravir) target the catalytic site of integrase, there are concerns about toxicity and resistance.
In contrast, STP0404 could be effective in patients who developed resistance to conventional HIV treatments, ST Pharm said.